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NCT01168973 · BASELINE

Baseline characteristics

A Study of Chemotherapy and Ramucirumab Versus Chemotherapy Alone in Second Line Non-Small Cell Lung Cancer (NSCLC) Participants Who Received Prior First Line Platinum-based Chemotherapy · Source last updated 2019-09-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

denoms
  1. counts
    1. group Id
      BG000
      value
      628
    2. group Id
      BG001
      value
      625
    3. group Id
      BG002
      value
      1253
    units
    Participants
groups
  1. description
    On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
    id
    BG000
    title
    Ramucirumab and Docetaxel
  2. description
    On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
    id
    BG001
    title
    Placebo and Docetaxel
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          391
        2. group Id
          BG001
          value
          407
        3. group Id
          BG002
          value
          798
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          237
        2. group Id
          BG001
          value
          218
        3. group Id
          BG002
          value
          455
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          209
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          419
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          419
        2. group Id
          BG001
          value
          415
        3. group Id
          BG002
          value
          834
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          96
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          387
        2. group Id
          BG001
          value
          380
        3. group Id
          BG002
          value
          767
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          198
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          390
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          29
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          160
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          33
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          526
        2. group Id
          BG001
          value
          503
        3. group Id
          BG002
          value
          1029
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          152
        3. group Id
          BG002
          value
          308
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          27
      title
      Taiwan
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          44
      title
      Greece
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          50
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          22
      title
      Israel
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          61
      title
      Russian Federation
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          54
      title
      Italy
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          26
      title
      Switzerland
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          55
      title
      India
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          45
      title
      France
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Puerto Rico
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          31
      title
      Netherlands
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Intent-to-Treat (ITT) population: All randomized participants grouped according to their assigned treatment at randomization.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      628
    2. group Id
      BG001
      value
      625
    3. group Id
      BG002
      value
      1253
    units
    Participants
groups
  1. description
    On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Ramucirumab DP: 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
    id
    BG000
    title
    Ramucirumab and Docetaxel
  2. description
    On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met. * Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously. * Docetaxel: 75 mg/m\^2 (60 mg/m\^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously.
    id
    BG001
    title
    Placebo and Docetaxel
  3. description
    Total of all reporting groups
    id
    BG002
    title
    Total
measures
  1. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          391
        2. group Id
          BG001
          value
          407
        3. group Id
          BG002
          value
          798
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          237
        2. group Id
          BG001
          value
          218
        3. group Id
          BG002
          value
          455
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          209
        2. group Id
          BG001
          value
          210
        3. group Id
          BG002
          value
          419
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          419
        2. group Id
          BG001
          value
          415
        3. group Id
          BG002
          value
          834
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          43
        2. group Id
          BG001
          value
          53
        3. group Id
          BG002
          value
          96
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          387
        2. group Id
          BG001
          value
          380
        3. group Id
          BG002
          value
          767
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          198
        2. group Id
          BG001
          value
          192
        3. group Id
          BG002
          value
          390
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. calculate Pct
    false
    classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          20
        3. group Id
          BG002
          value
          29
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          74
        2. group Id
          BG001
          value
          86
        3. group Id
          BG002
          value
          160
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          17
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          33
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          526
        2. group Id
          BG001
          value
          503
        3. group Id
          BG002
          value
          1029
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          0
        3. group Id
          BG002
          value
          1
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          156
        2. group Id
          BG001
          value
          152
        3. group Id
          BG002
          value
          308
      title
      United States
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          9
        2. group Id
          BG001
          value
          18
        3. group Id
          BG002
          value
          27
      title
      Taiwan
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          25
        2. group Id
          BG001
          value
          19
        3. group Id
          BG002
          value
          44
      title
      Greece
    4. categories
      1. measurements
        1. group Id
          BG000
          value
          27
        2. group Id
          BG001
          value
          23
        3. group Id
          BG002
          value
          50
      title
      Spain
    5. categories
      1. measurements
        1. group Id
          BG000
          value
          14
        2. group Id
          BG001
          value
          8
        3. group Id
          BG002
          value
          22
      title
      Israel
    6. categories
      1. measurements
        1. group Id
          BG000
          value
          28
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          61
      title
      Russian Federation
    7. categories
      1. measurements
        1. group Id
          BG000
          value
          26
        2. group Id
          BG001
          value
          28
        3. group Id
          BG002
          value
          54
      title
      Italy
    8. categories
      1. measurements
        1. group Id
          BG000
          value
          12
        2. group Id
          BG001
          value
          14
        3. group Id
          BG002
          value
          26
      title
      Switzerland
    9. categories
      1. measurements
        1. group Id
          BG000
          value
          22
        2. group Id
          BG001
          value
          33
        3. group Id
          BG002
          value
          55
      title
      India
    10. categories
      1. measurements
        1. group Id
          BG000
          value
          21
        2. group Id
          BG001
          value
          24
        3. group Id
          BG002
          value
          45
      title
      France
    11. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        2. group Id
          BG001
          value
          2
        3. group Id
          BG002
          value
          3
      title
      Puerto Rico
    12. categories
      1. measurements
        1. group Id
          BG000
          value
          15
        2. group Id
          BG001
          value
          16
        3. group Id
          BG002
          value
          31
      title
      Netherlands
    param Type
    NUMBER
    title
    Region of Enrollment
    unit Of Measure
    participants
population Description
Intent-to-Treat (ITT) population: All randomized participants grouped according to their assigned treatment at randomization.

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Preserved source evidence · Not medical advice